NPI Engineer II — MedTech Cardio Devices

Shockwave Medical; Santa Clara (CA); On-site; USD 87,000 - 140,000; Full time

Benefits offered by this job

Vacation time

Floating holidays

Parental Leave

Job summary

Johnson & Johnson is hiring an NPI Engineer II for the Santa Clara, CA site to drive process development for innovative peripheral, coronary, and heart valve devices. You will oversee pilot manufacturing/testing, support product transfers, and collaborate across R&D, operations, regulatory, and quality to bring products from development into production.

The role requires hands-on design and process validation capabilities, familiarity with Lean/Six Sigma, and experience in a fast-paced medical

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Min 3 years of experience in a medical device environment.
• Knowledge of QA systems including FDA/ISO/MDR requirements.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Lean and Six Sigma concepts and statistics basics are a plus.

Responsibilities

• Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
• Identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
• Coordinate and/or perform functional and destructive testing to support Engineering Reports with statistical analysis.
• Participate in new product introduction, including scaling up, stabilizing and transfer to alternate sites.
• Develop and maintain process FMEAs, MPIs, and DMR documents.
• Create and release label files for product labels.
• Create and execute process validation protocols and reports.
• Support Quality System activities and CAPA/ NCR events.

Skills

Sustaining support

Statistical analysis

Cross-functional collaboration

Process validation

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Oracle ERP/MES

Job description

Johnson & Johnson is hiring an NPI Engineer II for the Santa Clara, CA site to drive process development for innovative peripheral, coronary, and heart valve devices. You will oversee pilot manufacturing/testing, support product transfers, and collaborate across R&D, operations, regulatory, and quality to bring products from development into production.

The role requires hands-on design and process validation capabilities, familiarity with Lean/Six Sigma, and experience in a fast-paced medical